07/01/17: Commercial Medical Policy Update Bulletin: … for using the Medical Policy Update...

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share important information regarding UnitedHealthcare Medical Policy, Medical Benefit Drug Policy, Coverage Determination Guideline, Utilization Review Guideline, and Quality of

Care Guideline updates.*

*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.

July 2017

medical policy update bulletin Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

2 Medical Policy Update Bulletin: July 2017

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

Overview

Tips for using the Medical Policy Update Bulletin:

From the table of contents, click the policy title to be

directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a

complete copy of a new, updated, or revised policy.

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

requirements have been adopted for a service, procedure, test, or

device

Updated

An existing policy has been reviewed and changes have not been made

to the clinical coverage criteria or documentation review requirements;

however, items such as the clinical evidence, FDA information, and/or

list(s) of applicable codes may have been updated

Revised

An existing policy has been reviewed and revisions have been made to

the clinical coverage criteria and/or documentation review requirements

Replaced

An existing policy has been replaced with a new or different policy

Retired

The procedural codes and/or services previously outlined in the policy

are no longer being managed or are considered to be proven/medically

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

Note: The absence of a policy does not automatically indicate or imply

coverage. As always, coverage for a service or procedure must be

determined in accordance with the member’s benefit plan and any

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on UnitedHealthcare Medical

Policy, Medical Benefit Drug Policy, Coverage Determination

Guideline (CDG), Utilization Review Guideline (URG), and/or

Quality of Care Guideline (QOCG) updates. The inclusion of a

health service (e.g., test, drug, device or procedure) in this bulletin

indicates only that UnitedHealthcare has recently adopted a new

policy and/or updated, revised, replaced or retired an existing

policy; it does not imply that UnitedHealthcare provides coverage

for the health service. In the event of an inconsistency or conflict

between the information provided in this bulletin and the posted

policy, the provisions of the posted policy will prevail. Note that

most benefit plan documents exclude from benefit coverage health

services identified as investigational or unproven/not medically

necessary. Physicians and other health care professionals may not

seek or collect payment from a member for services not covered by

the applicable benefit plan unless first obtaining the member’s

written consent, acknowledging that the service is not covered by

the benefit plan and that they will be billed directly for the service.

The complete library of UnitedHealthcare Medical

Policies, Medical Benefit Drug Policies, CDGs, URGs, and

QOCGs is available at UnitedHealthcareOnline.com

> Tools & Resources > Policies, Protocols and Guides >

Medical & Drug Policies and Coverage Determination

Guidelines.

https://www.unitedhealthcareonline.com/b2c/CmaAction.do?channelId=cdc94e74bc62c010VgnVCM100000c520720a____



In This Issue

Medical Policy Updates Page

NEW

Laser Interstitial Thermal Therapy - Effective Oct. 1, 2017 .................................................................................................................................... 5

UPDATED

Abnormal Uterine Bleeding and Uterine Fibroids - Effective Jul. 1, 2017................................................................................................................... 5 Attended Polysomnography for Evaluation of Sleep Disorders - Effective Aug. 1, 2017 .............................................................................................. 6 Bronchial Thermoplasty - Effective Jul. 1, 2017 .................................................................................................................................................... 9 Chromosome Microarray Testing - Effective Aug. 1, 2017 ...................................................................................................................................... 9 Glaucoma Surgical Treatments - Effective Jul. 1, 2017 ........................................................................................................................................ 10 Home Traction Therapy - Effective Jul. 1, 2017 .................................................................................................................................................. 11 Implanted Electrical Stimulator for Spinal Cord - Effective Aug. 1, 2017 ................................................................................................................ 11 Light and Laser Therapy for Cutaneous Lesions and Pilonidal Disease - Effective Jul. 1, 2017 ................................................................................... 12 Meniscus Implant and Allograft - Effective Jul. 1, 2017 ........................................................................................................................................ 13 Motorized Spinal Traction - Effective Jul. 1, 2017 ................................................................................................................................................ 13 Obstructive Sleep Apnea Treatment - Effective Aug. 1, 2017 ................................................................................................................................ 14 Umbilical Cord Blood Harvesting and Storage for Future Use - Effective Jul. 1, 2017 ............................................................................................... 16

REVISED

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Sep. 1, 2017 ......................................................................... 18 Deep Brain and Cortical Stimulation - Effective Aug. 1, 2017................................................................................................................................ 20 Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Effective Aug. 1, 2017 ........................................................................... 22 Intensity-Modulated Radiation Therapy - Effective Sep. 1, 2017 ........................................................................................................................... 25 Proton Beam Radiation Therapy - Effective Sep. 1, 2017 ..................................................................................................................................... 26

Medical Benefit Drug Policy Updates

NEW

Brineura™ (Cerliponase Alfa) - Effective Sep. 1, 2017 ......................................................................................................................................... 28 Radicava™ (Edaravone) - Effective Sep. 1, 2017 ................................................................................................................................................ 29 White Blood Cell Colony Stimulating Factors - Effective Sep. 1, 2017 .................................................................................................................... 30

UPDATED

17-Alpha-Hydroxyproge-sterone Caproate (Makena™ and 17P) - Effective Jul. 1, 2017 ........................................................................................... 33 Stelara® (Ustekinumab) - Effective Jul. 1, 2017 .................................................................................................................................................. 34



In This Issue

REVISED

Off-Label/Unproven Specialty Drug Treatment - Effective Aug. 1, 2017 ................................................................................................................. 37

Coverage Determination Guideline (CDG) Updates

UPDATED

Cosmetic and Reconstructive Procedures - Effective Jul. 1, 2017 .......................................................................................................................... 39 Pectus Deformity Repair - Effective Jul. 1, 2017 ................................................................................................................................................. 39 Rhinoplasty and Other Nasal Surgeries - Effective Jul. 1, 2017 ............................................................................................................................. 40

REVISED

Preventive Care Services - Effective Oct. 1, 2017 ............................................................................................................................................... 45 Private Duty Nursing Services (PDN) - Effective Aug. 1, 2017 .............................................................................................................................. 46

Utilization Review Guideline (URG) Updates

REVISED

Office Based Program - Effective Oct. 1, 2017 .................................................................................................................................................... 49


Medical Policy Updates

Policy Title Effective Date Coverage Rationale

NEW

Laser Interstitial Thermal Therapy

Oct. 1, 2017 Laser interstitial thermal therapy is considered unproven and not medically necessary for treating ANY condition or diagnosis, including but not limited to: Brain tumors

Breast tumors (i.e., benign or malignant) Epilepsy (e.g., drug-resistant epilepsy, focal cortical dysplasias, mesial temporal lobe epilepsy) Prostate cancer

Radiation necrosis There is insufficient published evidence in the clinical literature supporting the safety and efficacy of this minimally invasive surgical procedure. Further studies are needed to determine whether such treatment is beneficial for health

outcomes.

Policy Title Effective Date Summary of Changes Coverage Rationale

UPDATED

Abnormal Uterine

Bleeding and Uterine Fibroids

Jul. 1, 2017

Updated coverage rationale:

o Modified list of examples of levonorgestrel-releasing

intrauterine devices (LNG-IUDs); added Kyleena™

Updated list of applicable HCPCS codes to reflect quarterly code edits; added Q9984

Updated supporting information to reflect the most current FDA information

Levonorgestrel-Releasing Intrauterine Device

Levonorgestrel-releasing intrauterine devices (LNG-IUD) (e.g., Mirena®, Skyla®, Liletta® or Kyleena™) are proven and medically

necessary for treating menorrhagia.

Refer to the U.S. Food and Drug Administration (FDA) section of the policy for additional information. Uterine Fibroids

Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids for women who do NOT wish to preserve their childbearing potential. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Uterine Artery Embolization,

ACG: A-0287 (AC).

Uterine artery embolization (UAE) is unproven and not medically necessary for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of UAE on ovarian and uterine function and on fertility are

relatively unknown. Further studies of safety and/or efficacy in published, peer-reviewed medical literature are necessary. Magnetic resonance-guided focused ultrasound ablation (MRgFUS) is unproven and not medically necessary for treating uterine fibroids.




UPDATED

Abnormal Uterine Bleeding and Uterine Fibroids

(continued)

Jul. 1, 2017 Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids. See the Benefit

Considerations section of the policy for potential coverage of unproven services.

Laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa™) is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this

procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids. Transcervical ultrasound-guided radiofrequency ablation is investigational, unproven and not medically necessary for treating uterine fibroids due to lack of FDA approval.

Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative

to other treatment options for uterine fibroids.

Attended Polysomnography

for Evaluation of Sleep Disorders

Aug. 1, 2017

Updated definition of “hypopnea” (no change to coverage rationale

or lists of applicable codes)

Home sleep apnea testing (HSAT), using a portable monitor, is medically necessary for evaluating adults with suspected OSA.

Where HSAT is indicated, an auto-titrating continuous positive airway pressure (APAP) device is an option to determine a fixed PAP pressure. Attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is medically necessary for evaluating individuals with suspected OSA when: Results of previous HSAT are negative, indeterminate or technically

inadequate to make a diagnosis of OSA; or

Patient is a child or adolescent (i.e., less than 18 years of age); or Patient is known to have one or more of the following comorbid medical

conditions that prohibits the use of a HSAT: o Significant chronic pulmonary disease as defined by a forced

expiratory volume (FEV1) % predicted of <60 (Pellegrino et al.,

2005) o Progressive neuromuscular disease/neurodegenerative disorder

(examples include, but are not limited to, Parkinson’s disease, myotonic dystrophy, amyotrophic lateral sclerosis, multiple sclerosis




UPDATED

Attended Polysomnography for Evaluation of

Sleep Disorders (continued)

Aug. 1, 2017

with associated pulmonary disease, history of stroke with persistent neurological sequelae)

o Moderate to severe heart failure (New York Heart Association class

III or IV) o Body mass index (BMI) >50 (DeMaria et al., 2007; Blackstone and

Cortés, 2010)

o Obesity hypoventilation syndrome o Documented ongoing epileptic seizures in the presence of symptoms

of sleep disorder.

Also, see Repeat Testing section below. When a diagnosis of OSA has been excluded or adequately treated, attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is medically necessary for evaluating symptomatic individuals suspected of having one (1) or

more of the following conditions: Severe chronic periodic limb movement disorder (PLMD) (not leg

movements associated with another disorder such as sleep disordered breathing)

Restless legs syndrome (RLS)/Willis-Ekbom disease that has not responded to treatment

Parasomnia with documented disruptive, violent or potentially injurious

sleep behavior suspicious of rapid eye movement sleep behavior disorder (RBD)

Narcolepsy, once other causes of excessive sleepiness have been ruled out (also see MSLT section below)

Central sleep apnea Attended full-channel nocturnal polysomnography, performed in a

healthcare facility or laboratory setting is not medically necessary for diagnosing ANY of the following conditions: Circadian rhythm disorders Depression Insomnia

There is insufficient published clinical evidence that evaluation of the above disorders with polysomnography (PSG) in the absence of symptoms of sleep disorder leads to better health outcomes.




UPDATED



Aug. 1, 2017

Actigraphy is not medically necessary for evaluating sleep-related breathing and circadian rhythm disorders. A review of the evidence does not establish the effectiveness of actigraphy as

a stand-alone tool for the diagnosis of OSA. In addition, definitive patient selection criteria for the use of actigraphy devices for the diagnosis of sleep apnea have not been established. The evidence regarding the use of

actigraphy for the evaluation of circadian rhythm disorders is of low quality; therefore, the clinical utility cannot be established. Daytime Sleep Studies

Multiple sleep latency testing (MSLT) is medically necessary for evaluating individuals with suspected narcolepsy when other causes

of excessive sleepiness have been excluded. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC). Maintenance of wakefulness testing (MWT) is medically necessary

for evaluating individuals whose inability to remain awake

constitutes a safety issue, or for assessing response to treatment in individuals with narcolepsy or idiopathic hypersomnia. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

Multiple sleep latency testing (MSLT) and the maintenance of wakefulness test (MWT) are not medically necessary for evaluating OSA, insomnia or circadian rhythm disorders. Available published evidence is insufficient to demonstrate improved management of these conditions through the use of MSLT. Published

evidence is limited to poorly controlled studies.

An abbreviated daytime sleep study (PAP-Nap), to acclimate individuals to PAP and its delivery, is not medically necessary. Further results from large, prospective studies are needed to assess the clinical value of this test. Attended PAP Titration

A split-night sleep study, performed in a healthcare facility or




UPDATED



Aug. 1, 2017

laboratory setting, is medically necessary for diagnosis and PAP titration when an individual meets the above criteria for an attended sleep study.

When a split-night sleep study is inadequate or not feasible, a full-night study, performed in a healthcare facility or laboratory setting,

is medically necessary for PAP titration when an individual meets the above criteria for an attended full-channel nocturnal polysomnography and has a confirmed diagnosis of OSA. Also, see Repeat Testing section below.

Attended Repeat Testing

It may be necessary to perform repeat sleep studies. Where repeat testing is indicated, attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is medically necessary for individuals who meet the above criteria for an attended sleep study. Repeat testing and repositioning/adjustments for oral sleep appliances can be done in the home unless the patient meets criteria for an attended sleep study.

Bronchial Thermoplasty

Jul. 1, 2017 Updated supporting information to reflect the most current clinical evidence, FDA information, and references; no change to coverage rationale or

list of applicable codes

Bronchial thermoplasty is unproven and not medically necessary for treating asthma. There is insufficient and low quality evidence regarding the use of bronchial thermoplasty in patients with severe asthma, who are resistant to standard therapies. Additional well-designed studies are needed to identify the long-

term safety and efficacy of bronchial thermoplasty for the treatment of severe asthma.

Chromosome Microarray Testing

Aug. 1, 2017

Updated list of applicable ICD-10 diagnosis codes; added Q89.8 (no change to coverage

rationale)

Genome-wide comparative genomic hybridization microarray testing or single nucleotide polymorphism (SNP) chromosomal microarray analysis is proven and medically necessary for evaluating an

embryo/fetus in the following cases: Women undergoing invasive prenatal testing (i.e., amniocentesis,

chorionic villus sampling or fetal tissue sampling) Intrauterine fetal demise or stillbirth Genome-wide comparative genomic hybridization microarray testing

or single nucleotide polymorphism (SNP) chromosomal microarray analysis is proven and medically necessary for evaluating patients with one or more of the following:




UPDATED

Chromosome Microarray Testing (continued)

Aug. 1, 2017

Multiple anomalies not specific to a well-delineated genetic syndrome and cannot be identified by a clinical evaluation alone

Non-syndromic developmental delay/intellectual disability

Autism spectrum disorders Genome-wide comparative genomic hybridization microarray testing

and single nucleotide polymorphism (SNP) chromosomal microarray analysis are unproven and not medically necessary for all other patient populations and conditions including but not limited to the following:

Preimplantation genetic diagnosis or screening in embryos Diagnosis, management, and prognosis of cancer

There is insufficient evidence in the clinical literature demonstrating that genome-wide comparative genomic hybridization (CGH) microarray testing

or single nucleotide polymorphism (SNP) chromosomal microarray analysis has a role in clinical decision-making or has a beneficial effect on health outcomes for other conditions such as preimplantation genetic diagnosis or screening in embryos or aiding diagnosis or tumor classification or

determining the most appropriate treatment and establishing an accurate prognosis for cancer. Further studies are needed to determine the analytic

validity, clinical validity and clinical utility of this test for indications other than those listed above as proven. Genetic Counseling

Genetic counseling is strongly recommended prior to this test in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.

Glaucoma Surgical Treatments

Jul. 1, 2017

Updated list of applicable CPT codes to reflect quarterly code

edits; added 0474T

Glaucoma drainage devices, such as the ExPRESS™ mini glaucoma shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or

the Ahmed glaucoma valve implant, are proven and medically necessary for treating refractory glaucoma when conventional medical or surgical treatments have failed or are inappropriate. The iStent® Trabecular Micro-Bypass Stent System is proven and

medically necessary when used in combination with cataract surgery for treating mild to moderate open-angle glaucoma and a cataract in adults currently being treated with ocular hypotensive medication. The CyPass® Micro-Stent System is unproven and not medically




UPDATED

Glaucoma Surgical Treatments (continued)

Jul. 1, 2017 necessary when used in combination with cataract surgery for treating mild-to-moderate primary open-angle glaucoma (POAG).

The Xen Glaucoma Treatment System is unproven and is not medically necessary for treating refractory glaucoma when conventional medical or surgical treatments have failed, or in

patients with primary open-angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

Glaucoma drainage devices, such as Eyepass, DeepLight SOLX® Gold Shunt and other shunts that do not have FDA approval are investigational and unproven and not medically necessary for treating glaucoma. Clinical evidence is limited to small studies; therefore, additional studies are needed to establish the safety and efficacy of these devices.

Canaloplasty is proven and medically necessary for treating primary

open-angle glaucoma. Viscocanalostomy is unproven and not medically necessary for treating glaucoma. Evidence from the majority of available randomized controlled trials indicates

that viscocanalostomy is not as effective as trabeculectomy in reducing intraocular pressure (IOP).

Home Traction Therapy

Jul. 1, 2017 Updated supporting information to reflect the most current clinical evidence and references;

no change to coverage rationale

or list of applicable codes

Home traction therapy is unproven and not medically necessary for treating low back and neck disorders with or without radiculopathy.

The majority of studies are office based with mixed results. The quality of peer reviewed studies for home traction are limited as well to conclude that it

is effective in the management of neck or low back pain or that it improves

health outcomes. The indications for clinical application, patient selection criteria, risks, and comparison to alternative technologies have not been established for home traction therapy.

Implanted

Electrical Stimulator for Spinal Cord

Aug. 1, 2017

Updated coverage rationale;

added reference link to the Medical Policy titled Electrical Stimulation for the Treatment of

For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 21st edition, 2017, Implanted Electrical Stimulator, Spinal Cord ACG: A-0243 (AC).

Note: For Dorsal Root Ganglion (DRG) stimulation, please refer to the




UPDATED

Implanted Electrical Stimulator for

Spinal Cord (continued)

Aug. 1, 2017 Pain and Muscle Rehabilitation for information pertaining to dorsal root ganglion (DRG)

stimulation

Medical Policy titled Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation.

Light and Laser Therapy for Cutaneous Lesions

and Pilonidal Disease

Jul. 1, 2017

Updated benefit considerations; replaced language indicating “several states mandate

coverage for laser therapy for treatment of port-wine stains and cutaneous hemangiomata under certain circumstances” with “certain states allow coverage of laser therapy for

treatment of port-wine stains and cutaneous hemangiomata under certain circumstances”

Updated supporting information to reflect the most current clinical evidence, CMS information, and references; no

change to coverage rationale or lists of applicable codes

Port-Wine Stains and Cutaneous Hemangiomata

Pulsed dye laser therapy is proven and medically necessary for treating port-wine stains and cutaneous hemangiomata. Rosacea and Rhinophyma

Light and laser therapy including intense pulsed light are unproven and not medically necessary for treating rosacea and rhinophyma.

The quantity and quality of the evidence is insufficient to recommend light and laser treatment for the treatment of rosacea and rhinophyma. The quality of evidence is limited. Additional research is needed to determine efficacy and safety and to clarify patient selection and treatment parameters. Acne Vulgaris

Light and laser therapy including light phototherapy, photodynamic therapy, intense pulsed light, and pulsed dye laser are unproven and not medically necessary for treating active acne vulgaris.

There is insufficient evidence to recommend the use of light and laser therapy for the treatment acne vulgaris. Studies evaluating light and laser therapy for acne typically are short term, lack controls or the patient serves as their own control, have small sample sizes, and do not compare laser therapy with standard acne treatment. Well-designed studies are necessary to clarify the role of light and laser therapy for acne. Pilonidal Sinus Disease

Laser hair removal is unproven and not medically necessary for

treating pilonidal sinus disease. There is insufficient evidence to conclude that laser hair removal is effective for treating pilonidal sinus disease. Most of the studies regarding this treatment were small and uncontrolled. Additional well-designed controlled trials are needed to determine the efficacy of laser hair removal for pilonidal disease.




UPDATED

Meniscus Implant and Allograft

Jul. 1, 2017

Updated supporting information to reflect the most current description of services, clinical

evidence, FDA information, and references; no change to coverage rationale or lists of

applicable codes

Meniscus allograft transplantation with human cadaver tissue is proven and medically necessary for replacement of major meniscus loss due to trauma or previous meniscectomy when ALL of the

following criteria are met: Patient who is skeletally mature with documented closure of growth

plates

Patient has significant knee pain and limited function Patient is missing more than half of the meniscus due to surgery or

injury or has a tear that cannot be repaired Radiographic criteria established by a standing anteroposterior (AP) view

demonstrates all of the following: o Normal alignment or correctable varus or valgus deformities o No osteophytes or marginal osteophytes o No irreparable articular cartilage defects o No significant joint space narrowing

Ligamentous stability has been achieved prior to surgery or achieved

concurrently with meniscal transplantation (e.g., concomitant anterior cruciate ligament surgery)

Documented minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge Grade II or less)

There is no evidence of active inflammatory arthritis or systemic arthritis Patient who has failed conservative treatment including physical therapy

and/or bracing techniques.

Collagen meniscus implants are unproven and not medically necessary for treating or evaluating and managing meniscus injuries or tears. There is insufficient evidence that collagen meniscus implants improve health outcomes such as reduction of symptoms and restoration of knee function in patients with meniscus injuries or tears. Additional studies with long term

follow-up are needed to determine whether implantation of a collagen scaffold is able to slow joint degeneration, delay the progression of osteoarthritis, and reduce pain for long durations.

Motorized Spinal

Traction

Jul. 1, 2017

Updated supporting information

to reflect the most current clinical evidence, CMS information, and references; no change to coverage rationale or

Motorized spinal traction devices are unproven and not medically

necessary for treating neck and low back disorders. There is insufficient evidence from peer-reviewed published studies to conclude that spinal unloading devices are effective in the management of neck or low back pain or that they improve health outcomes. The indications




UPDATED

Motorized Spinal Traction (continued)

Jul. 1, 2017 list of applicable codes

for use, patient selection criteria, risks, and comparison to alternative technologies have not been established by the U.S. Food and Drug Administration (FDA) for motorized traction therapy.

(Accessed April 20, 2017)

Obstructive Sleep

Apnea Treatment

Aug. 1, 2017

Updated coverage rationale;

replaced language indicating “removable oral appliances are proven and medically necessary

for treating obstructive sleep apnea (OSA) as documented by polysomnography” with “removable oral appliances are proven and medically necessary for treating obstructive sleep

apnea (OSA) as documented by a sleep study (e.g., polysomnography or home sleep

apnea testing)” Updated definitions:

o Removed language indicating:

According to the American Academy of Sleep Medicine (AASM), the diagnosis of OSA is confirmed if the number of obstructive events† (apneas, hypopneas +

respiratory event related

arousals) on polysomnography (PSG) is greater than 15 events/hour or greater than 5/hour in a patient

who reports any of the following: - Unintentional sleep

episodes during

Nonsurgical Treatment

Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) as documented by a sleep study (e.g., polysomnography or home sleep apnea testing). Refer to the Medical Policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information.

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG). Removable oral appliances are unproven and not medically

necessary for treating central sleep apnea.

This type of sleep apnea is caused by impaired neurological function, and these devices are designed to manage physical obstructions. Nasal dilator devices are unproven and not medically necessary for treating obstructive sleep apnea (OSA). There is insufficient clinical evidence supporting the safety and efficacy of

nasal dilators for treating OSA. Results from available studies indicate that therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its long-term effectiveness and to determine which patients would benefit from this therapy.

Surgical Treatment

The following surgical procedures are proven and medically necessary for treating obstructive sleep apnea as documented by polysomnography.

Refer to the Medical Policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Also, see the Definitions section of the policy for information on the definitions and severity of OSA. Uvulopalatopharyngoplasty (UPPP): For information regarding

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm




UPDATED

Obstructive Sleep Apnea Treatment (continued)

Aug. 1, 2017

wakefulness - Daytime sleepiness - Unrefreshing sleep

- Fatigue - Insomnia - Waking up breath

holding, gasping or choking

- The bed partner describing loud

snoring, breathing interruptions or both during the patient’s sleep

† The frequency of obstructive events is

reported as an apnea-hypopnea index (AHI) or

respiratory disturbance index (RDI) - RDI has at times

been used synonymously with

AHI, but at other times has included the total of apneas, hypopneas and respiratory effort related arousals (RERAs) per hour of

sleep - When a portable

monitor is used that does not measure sleep, the RDI refers to the number of

apneas plus hypopneas per hour of recording

medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Uvulopalatopharyngoplasty (UPPP), A-0245 (ACG).

Maxillomandibular Advancement Surgery (MMA): For information

regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG). Also, see the Coverage Determination

Guideline titled Orthognathic (Jaw) Surgery. Multilevel Procedures Whether Done in a Single Surgery or

Phased Multiple Surgeries: There are a variety of procedure combinations, including mandibular osteotomy and genioglossal

advancement with hyoid myotomy (GAHM). For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Mandibular Osteotomy, A-0247 (ACG).

The following surgical procedures are unproven and not medically necessary for treating obstructive sleep apnea:

Laser-assisted uvulopalatoplasty (LAUP) Palatal implants

Lingual suspension - also referred to as tongue stabilization, tongue stitch or tongue fixation

Transoral robotic surgery (TORS) Implantable hypoglossal nerve stimulation Radiofrequency ablation of the soft palate and/or tongue base

There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved apnea-hypopnea index (AHI) or secondary outcomes. Some studies saw a worsening of symptoms as well as increased complications. Results of studies provide preliminary but inconsistent evidence that palatal

implants benefit patients with mild to moderate OSA. However, the magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the available studies involved ≤ 1 year of patient monitoring after treatment. Additional studies are needed to determine the role of palatal implants in the management of OSA.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of lingual suspension in the treatment of OSA. The published peer-




UPDATED

Obstructive Sleep Apnea Treatment (continued)

Aug. 1, 2017 o Added definition of: Apnea Apnea hypopnea index

(AHI) Home sleep apnea

testing

Hypopnea Obstructive sleep apnea Respiratory disturbance

index (RDI)

Respiratory effort-related arousal (RERA)

Respiratory event index (REI)

Updated supporting information to reflect the most current

description of services, clinical evidence, CMS information, and

references

reviewed medical literature includes a few small, uncontrolled studies with short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of transoral robotic surgery (TORS) in the treatment of OSA.

Large, controlled studies, with long-term follow-up, comparing TORS to established procedures are necessary. There is insufficient evidence to support the safety, efficacy and long-term

outcomes of hypoglossal nerve stimulation in the treatment of OSA. The optimal patient selection criteria for the use of hypoglossal nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve stimulation to established procedures are necessary to evaluate the effectiveness of this technology.

There is insufficient evidence to support the efficacy and long-term outcomes

of radiofrequency ablation of the tongue or soft palate in the treatment of OSA. Optimal patient selection criteria have not been defined. Large controlled studies or comparative effectiveness trials with long-term follow-up comparing radiofrequency ablation to established procedures are necessary.

Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to the Medical Policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information.

Umbilical Cord

Blood Harvesting and Storage for Future Use

Jul. 1, 2017

Updated list of related policies:

o Added reference link to Clinical Guideline titled Hematopoietic Stem Cell Transplantation Review Guidelines

o Removed reference link to Clinical Guideline titled Transplant Review Guidelines

Updated benefit considerations:

Collection and storage of umbilical cord blood for possible later use is

unproven and not medically necessary for a person currently healthy but desiring to provide the opportunity for a hypothetical, future transplantation. Published clinical evidence on the use of umbilical cord blood is limited to diagnosis-specific indications for persons who would otherwise be eligible for

bone marrow or stem cell transplants. Current available clinical evidence does not support the hypothesis that storage for hypothetical future use improves health outcomes.




UPDATED

Umbilical Cord Blood Harvesting and Storage for

Future Use (continued)

Jul. 1, 2017 o Removed language indicating long term storage services do not meet the

definition of a Covered Health Service

o Modified list of examples of

long term storage service exclusions; replaced “any other body or body parts” with “any other body parts”

Updated coverage rationale: o Modified language pertaining

to clinical evidence/study findings; replaced language indicating “published clinical evidence on the use of

umbilical cord blood is limited to diagnosis-specific

indications for persons who would otherwise be eligible for human leukocyte antigen (HLA)-compatible allogeneic bone marrow or stem cell

transplants” with “published clinical evidence on the use of umbilical cord blood is limited to diagnosis-specific indications for persons who would otherwise be eligible for bone marrow or stem cell

transplants” Updated supporting information

to reflect the most current clinical evidence and references

For additional information and coverage of umbilical cord blood stem cell transplantation, please refer to the UnitedHealth Group Hematopoietic Stem Cell Transplantation Review Guidelines.




REVISED

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes

Sep. 1, 2017

Updated list of related policies; removed reference link to Medical Policy titled Intermittent

Intravenous Insulin Therapy (retired Feb. 1, 2017)

Updated benefit considerations;

removed examples of applicable benefit plan documents

Revised coverage rationale: o Replaced language

indicating: “External insulin pumps

that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for

patients with type 1 or insulin-requiring type 2

diabetes who currently perform ≥4 insulin injections and ≥4 blood glucose measurements daily” with “external

insulin pumps that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for patients with type 1 or insulin-requiring type 2

diabetes” “Long-term continuous

glucose monitoring for personal use at home is proven and medically necessary as a

supplement to self-monitoring of blood glucose (SMBG) for

Insulin Delivery

External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for patients with type 1 or insulin-requiring type 2 diabetes. For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 21st edition, 2017, Insulin Infusion Pump ACG:A-

0339 (AC). Note: Programmable disposable external insulin pumps (e.g., Omnipod) are considered equivalent to standard insulin pumps. Nonprogrammable transdermal insulin delivery systems (e.g., V-Go)

are unproven and not medically necessary for treating patients with diabetes. There is insufficient evidence in the clinical literature demonstrating the safety and efficacy of transdermal insulin delivery in the management of patients with diabetes.

Implantable insulin pumps are investigational, unproven and not

medically necessary. No implantable insulin pumps have received U.S. Food and Drug Administration (FDA) approval at this time. While some preliminary studies reported improved glycemic control and fewer episodes of hypoglycemia in carefully selected patients, complications such as catheter blockage and infection were observed. Larger, randomized controlled trials are needed to

determine the long-term impact of implantable insulin pumps on diabetes management. Insulin infuser ports are unproven and not medically necessary for insulin delivery in patients with diabetes.

There is insufficient evidence demonstrating that the use of insulin infuser ports results in improved glycemic control beyond what can be achieved by

using standard insulin delivery methods. In addition, an increase in complications, such as infection at the port site, has been reported when using these devices. Further well-designed, large-scale randomized controlled trials are needed to establish the safety and efficacy of these devices. See the Description of Services section of the policy for further details on the




REVISED


Managing Diabetes (continued)

Sep. 1, 2017

patients with type 1 diabetes who have demonstrated adherence

to a physician ordered diabetic treatment plan” with “long-term

continuous glucose monitoring for personal use at home is proven and medically necessary

for patients with type 1 diabetes who have demonstrated adherence to a physician ordered diabetic treatment plan”

o Added example of brand

name product for: Programmable

disposable external insulin pumps (Omnipod®)

Nonprogrammable transdermal insulin

delivery systems (V-Go) Implantable glucose

sensors (Eversense®) o Added language to indicate

continuous glucose monitoring using a noninvasive device is

investigational, unproven, and not medically necessary due to lack of FDA approval There are no

commercially available noninvasive systems at

this time There is insufficient

published clinical

various types of insulin delivery systems. Continuous Glucose Monitoring

Short-term (3-7 days) continuous glucose monitoring by a healthcare provider for diagnostic purposes is proven and medically

necessary for patients with diabetes.

Long-term continuous glucose monitoring for personal use at home is proven and medically necessary for patients with type 1 diabetes who have demonstrated adherence to a physician ordered diabetic treatment plan. For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 21st edition, 2017, Continuous Glucose Monitoring ACG:A-0126 (AC). Long-term continuous glucose monitoring for personal use at home is unproven and not medically necessary for patients with type 2 diabetes or gestational diabetes.

There is insufficient evidence that the use of long-term continuous glucose

monitoring leads to improvement of glycemic control in patients with type 2 or gestational diabetes. Continuous glucose monitoring using an implantable glucose sensor (e.g., Eversense) is investigational, unproven and not medically necessary due to lack of U.S. Food and Drug Administration (FDA)

approval. There is insufficient published clinical evidence to conclude that the use of continuous glucose monitoring using an implantable gluocose sensor leads to an improvement in glycemic control. The small sample sized studies lack adequate controls, randomization and blinding.

Continuous glucose monitoring using a noninvasive device is investigational, unproven and not medically necessary due to lack of

FDA approval. There are no commercially available noninvasive systems at this time. There is insufficient published clinical evidence to assess the safety and efficacy of continuous glucose monitoring using a noninvasive device.




REVISED


Managing Diabetes (continued)

Sep. 1, 2017 evidence to assess the safety and efficacy of continuous glucose

monitoring using a noninvasive device

o Removed language

indicating remote glucose monitoring is unproven and not medically necessary for managing patients with

diabetes Updated list of applicable HCPCS

codes: o Added K0553 and K0554 o Removed A9275 and E0607


to reflect the most current description of services, clinical

evidence, FDA and CMS information, and references

Deep Brain and

Cortical Stimulation

Aug. 1, 2017

Revised coverage rationale:

o Replaced language indicating “deep brain stimulation is proven and medically necessary for treating the listed indications” with “deep brain stimulation (excluding directional deep brain

stimulation) is proven and

medically necessary for treating the listed indications”

o Added language to indicate directional deep brain

stimulation that enables specific steering of current towards targeted lesions (e.g., Infinity™ DBS System)

Deep Brain Stimulation

Deep brain stimulation (excluding directional deep brain stimulation) is proven and medically necessary for treating the following:

Idiopathic Parkinson's disease when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions.

Essential tremor when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions.

Primary dystonia (occurs apart from any other identifiable illness)

including generalized and/or segmental dystonia, hemidystonia and cervical dystonia (torticollis) when used according to the U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions.

Deep brain stimulation is unproven and not medically necessary for

treating secondary Parkinsonism (result of head trauma, metabolic conditions, toxicity, drugs, or other medical disorders).




REVISED

Deep Brain and Cortical Stimulation (continued)

Aug. 1, 2017

is unproven and not medically necessary for treating any condition

including Parkinson’s disease, dystonia, or tremor There is limited evidence

comparing directional deep brain stimulation with traditional deep brain stimulation

methods of stimulation Long-term follow-up of

large cohorts are needed to determine the effectiveness and long-term results of

directional deep brain stimulation

Updated supporting information to reflect the most current description of services, clinical evidence, FDA and CMS information, and references

Well-designed studies demonstrating the efficacy of deep brain stimulation for treating secondary Parkinsonism are not available. Clinical trials are needed to demonstrate the benefit of deep brain stimulation for this patient

population. Deep brain stimulation is unproven and not medically necessary for

treating secondary dystonia (occurs with illness, after trauma or following exposure to certain medications or toxins). There is inadequate evidence of the safety and efficacy of deep brain stimulation for treating secondary dystonia. Questions remain with regard to

patient selection criteria and long-term benefits and safety compared with standard treatments. Formal comparisons, with large randomized controlled or comparative trials of pallidotomy, thalamotomy, and deep brain stimulation, are required before conclusions can be drawn regarding the use of deep brain stimulation for patients with secondary dystonia.

Deep brain stimulation is unproven and not medically necessary for treating conditions other than those listed as proven.

This includes but is not limited to the following diagnoses: Depression Obsessive-compulsive disorder (OCD) Epilepsy Tourette syndrome

Cluster headache Impulsive or violent behavior Chronic pain Trigeminal neuralgia Movement disorders caused by multiple sclerosis (MS) Phantom limb pain Stroke pain

Due to limited studies, small sample sizes, weak study designs and heterogenous patient characteristics, there is insufficient data to conclude that deep brain stimulation is safe and/or effective for treating these indications. Directional deep brain stimulation that enables specific steering of

current towards targeted lesions (e.g., InfinityTM DBS System) is unproven and not medically necessary for treating any condition including Parkinson’s disease, dystonia, or tremor.




REVISED

Deep Brain and Cortical Stimulation (continued)

Aug. 1, 2017

There is limited evidence comparing directional deep brain stimulation with traditional deep brain stimulation methods of stimulation. Long-term follow-up of large cohorts are needed to determine the effectiveness and long-term

results of directional deep brain stimulation. Responsive Cortical Stimulation

Responsive cortical stimulation (e.g., NeuroPace® RNS® System) is proven and medically necessary for treating partial onset seizures in patients who meet ALL of the following criteria: 18 years of age or older; and Partial onset seizures with all of the following:

o Undergone diagnostic testing that localized no more than two

epileptogenic foci, and o Seizures are refractory to therapeutic dosing of two or more

antiepileptic medications, and o Currently experiencing an average of three or more disabling

seizures (e.g., motor, partial seizures, complex partial seizures and/or secondarily generalized seizures) per month over the most

recent three months (with no month with fewer than two seizures)

Responsive cortical stimulation is unproven and not medically necessary for treating conditions in patients who do not meet the above criteria.

Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation

Aug. 1, 2017

Revised coverage rationale: o Modified existing

unproven/not medically necessary statements; added language to clarify the procedures are unproven/not

medically necessary for

treating the listed indication(s)

o Added language to indicate: Microcurrent electrical

nerve stimulation (MENS) therapy is

unproven and not medically necessary

When used for walking, functional electrical stimulation (FES), a form of neuromuscular electrical stimulation (NMES), is proven and medically necessary when used as one component of a comprehensive rehabilitation program in persons with paralyzed lower limbs due to spinal cord injury (SCI) with all of the following characteristics:

Intact lower motor units (L1 and below) (both muscle and peripheral

nerves) Muscle and joint stability for weight bearing at upper and lower

extremities that can demonstrate balance and control to maintain an upright support posture independently;

Demonstrate brisk muscle contraction to NMES and have sensory perception of electrical stimulation sufficient for muscle contraction;

Possess high motivation, commitment and cognitive ability to use such devices for walking;




REVISED

Electrical Stimulation for the Treatment of Pain

and Muscle Rehabilitation (continued)

Aug. 1, 2017

- There is insufficient evidence to conclude that microcurrent

electrical nerve stimulation is safe and effective

- Robust clinical trials are needed to evaluate this therapy in comparison to

other types of treatment

Dorsal root ganglion (DRG) stimulation is unproven and not medically necessary

- There is limited evidence in the peer

reviewed literature to support that DRG stimulation will improve health outcomes in patients

with pain - Randomized

controlled trials assessing larger patient groups and long-term follow up are needed to

further clarify its role - A description of

dorsal root ganglion neurostimulation devices is located in the U.S. Food and

Drug Administration (FDA) section of the policy

Able to transfer independently and demonstrate independent standing tolerance for at least 3 minutes;

Demonstrate hand and finger function to manipulate controls;

Post recovery from SCI and restorative surgery of at least 6-months; No hip and knee degenerative disease and no history of long bone

fracture secondary to osteoporosis

Functional electrical stimulation (FES) is unproven and not medically necessary for treating ANY other indication not listed above as proven and medically necessary, including but not limited to:

Disuse muscle atrophy in persons with spinal cord injury (SCI) Disuse muscle atrophy in persons with multiple sclerosis (MS) Gait disorders (e.g., foot drop) of central neurologic origin, including but

not limited to stroke or MS Further studies are needed to confirm that FES promotes bone

remineralization and prevents or reverses muscle atrophy. Only a few studies have looked at FES as a modality of treatment of MS, and the results are

limited and conflicting regarding whether FES improves treatment outcomes in MS when offered in addition to other rehabilitative treatment modalities. There is insufficient evidence in the peer reviewed literature that use of FES will improve health outcomes in patients with gait disorders. Published studies have included small heterogeneous patient populations, short-term

follow-ups, and various treatment protocols, outcome measures, and FES devices. Neuromuscular electrical stimulation (NMES) is proven and medically necessary for treating the following indications: Disuse muscle atrophy if:

o The nerve supply to the muscle is intact; and

o The disuse muscle atrophy is not of neurological origin but originates from conditions such as casting, splinting or contractures.

To improve wrist and finger function and prevent or correct shoulder subluxation in persons with partial paralysis following stroke

Neuromuscular electrical stimulation (NMES) is unproven and not

medically necessary for treating ANY other indication not listed above as proven and medically necessary. There is insufficient evidence in the peer reviewed literature that use of




REVISED



Aug. 1, 2017

Updated list of applicable HCPCS codes; added E1399


to reflect the most current description of services, clinical evidence, FDA and CMS

information, and references

electrical stimulation will improve health outcomes for the treatment of multiple conditions other than those identified above as proven. Overall, studies in the form of randomized controlled trials and case series included

small, heterogeneous patient populations and short-term follow-ups. Some systematic reviews have reported that no improvement was seen with NMES, outcomes were conflicting and/or in some cases, when improvement was

noted, the effects did not last. Heterogeneity of treatment regimens and outcome measures make it difficult to establish that NMES resulted in meaningful clinical outcomes (e.g., decrease pain, functional improvement, improvement in quality of life and ability to carry out activities of daily living)

for these other conditions and indications. Interferential therapy (IFT) is unproven and not medically necessary for treating the following indications: For the treatment of musculoskeletal disorders or injuries For stimulating healing of nonsurgical soft tissue injuries

To facilitate the healing of bone fractures

There is limited evidence from the available studies to conclude that IFT reduces the pain or promotes healing of bone fractures, musculoskeletal or nonsurgical soft tissue injuries. Although a few studies reported some improvement in pain or disability following IFT for these conditions, none of the double-blind, randomized, placebo-controlled studies reported a positive

treatment effect of IFT for nonsurgical soft tissue injuries or bone fractures. Pulsed electrical stimulation (PES) is unproven and not medically necessary for treating osteoarthritis. There is insufficient evidence to conclude that PES provides health benefits to patients with osteoarthritis. Randomized, controlled trials are necessary to assess the durability of this procedure in comparison to other types of

treatment. Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is unproven and not medically necessary for treating pain. Evidence for the effectiveness of PSFS or PNFS based on controlled studies is

lacking. Randomized controlled trials are needed to evaluate the efficacy of this treatment.




REVISED



Aug. 1, 2017 Microcurrent electrical nerve stimulation (MENS) therapy is unproven and not medically necessary. There is insufficient evidence to conclude that microcurrent electrical nerve

stimulation is safe and effective. Robust clinical trials are needed to evaluate this therapy in comparison to other types of treatment.

Dorsal root ganglion (DRG) stimulation is unproven and not medically necessary. There is limited evidence in the peer reviewed literature to support that DRG stimulation will improve health outcomes in patients with pain. Randomized

controlled trials assessing larger patient groups and long-term follow up are needed to further clarify its role. A description of dorsal root ganglion neurostimulation devices is located in the U.S. Food and Drug Administration (FDA) section of the policy.

Intensity-Modulated

Radiation Therapy

Sep. 1, 2017

Revised coverage rationale; replaced language indicating:

o “Intensity-modulated radiation therapy (IMRT) is proven and medically necessary for treating the

primary site of the [listed] diagnoses” with “IMRT is proven and medically necessary for definitive therapy of the primary site of the [listed] diagnoses”

o “IMRT may be covered for a

diagnosis that is not listed

above as proven when at least one of the [listed] conditions is present” with “IMRT may be covered for a diagnosis that is not listed

above as proven, including recurrences or metastases in selected cases, when at least one of the [listed] conditions

This policy applies to persons 19 years of age and older. Intensity-modulated radiation therapy (IMRT) is covered without further

review for persons 18 years and younger. IMRT is proven and medically necessary for definitive therapy of the primary site of the following diagnoses:

Anal cancer Breast cancer when the patient has a separation of 25.5 cm or more in

the intra-thoracic distance from the midpoint of the posterior light field border of the medial tangential field to the midpoint of the posterior light field of the lateral tangential field

Cervical cancer in patients who have had a hysterectomy Esophageal cancer

Head and neck cancers, including the following areas: pharynx

(nasopharynx, oropharynx and hypopharynx), larynx, salivary glands, oral cavity (includes the tongue), nasal cavity and paranasal sinuses

Mediastinal tumors Pancreatic cancer Primary or benign tumors of the central nervous system including the

brain, brainstem and spinal cord Prostate cancer Tracheal cancer




REVISED

Intensity-Modulated Radiation Therapy

(continued)

Sep. 1, 2017 is present” Added definition of “definitive

therapy”

IMRT may be covered for a diagnosis that is not listed above as proven, including recurrences or metastases in selected cases, when at least one of the following conditions is present:

A non-IMRT technique would substantially increase the probability of clinically meaningful normal tissue toxicity.

The same or an immediately adjacent area has been previously

irradiated, and the dose distribution within the patient must be sculpted to avoid exceeding the cumulative tolerance dose of nearby normal tissue.

Requests for these exceptions will be evaluated on a case-by-case basis. The use of compensator based beam modulation treatment is proven and medically necessary when done in combination with an IMRT indication that is listed above as proven.

IMRT used in conjunction with proton beam radiation therapy is unproven and not medically necessary.

Clinical evidence is insufficient to support the combined use of these technologies in a single treatment plan. Comparative effectiveness studies including randomized controlled trials are needed to demonstrate the safety and long-term efficacy of combined therapy.

Proton Beam Radiation Therapy

Sep. 1, 2017

Revised coverage rationale: o Replaced language indicating

“proton beam radiation therapy is proven and medically necessary for treating the [listed]

indications” with “proton

beam radiation therapy is proven and medically necessary for definitive therapy of the [listed] indications”

o Updated list of indications for which proton beam radiation therapy is unproven and not medically necessary for;

Proton beam radiation therapy is proven and medically necessary for definitive therapy of the following indications: Intracranial arteriovenous malformations (AVMs) Ocular tumors, including intraocular/uveal melanoma (includes the iris,

ciliary body and choroid) Skull-based tumors (e.g., chordomas, chondrosarcomas or paranasal

sinus tumors)

Proton beam radiation therapy is unproven and not medically necessary for treating ALL other indications, including but not limited to: Age-related macular degeneration (AMD) Bladder cancer

Brain and spinal cord tumors Breast cancer Choroidal hemangioma Esophageal cancer




REVISED

Proton Beam Radiation Therapy (continued)

Sep. 1, 2017

added breast cancer o Added language to indicate

proton beam radiation

therapy may be covered for a diagnosis that is not listed as proven, including

recurrences or metastases in selected cases, when documentation is provided that sparing of the

surrounding normal tissue cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT) and

stereotactic body radiation therapy (SBRT); requests for

these exceptions will be evaluated on a case-by-case basis

Added definition of “definitive therapy”

Updated supporting information to reflect the most current clinical evidence and references

Gynecologic cancers Head and neck cancers Hepatocellular carcinoma

Lung cancer Lymphomas Pancreatic cancer

Prostate cancer Vestibular tumors (e.g., acoustic neuroma or vestibular schwannoma) There is limited clinical evidence that directly compares proton beam therapy

(PBT) with other types of radiation therapy. Current published evidence does not allow for any definitive conclusions about the safety and efficacy of proton beam therapy to treat conditions other than those noted above as proven and medically necessary. Proton beam radiation therapy may be covered for a diagnosis that is

not listed above as proven, including recurrences or metastases in selected cases, when documentation is provided that sparing of the

surrounding normal tissue cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT). Requests for these exceptions will be evaluated on a case-by-case basis.

Proton beam radiation therapy used in conjunction with intensity-modulated radiation therapy (IMRT) is unproven and not medically necessary. Clinical evidence is insufficient to support the combined use of these technologies in a single treatment plan. Comparative effectiveness studies including randomized controlled trials are needed to demonstrate the safety

and long-term efficacy of combined therapy.




NEW

Brineura™ (Cerliponase Alfa)

Sep. 1, 2017

Brineura is proven and medically necessary for slowing the loss of ambulation in symptomatic pediatric patients with Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency when all of the following criteria are met:

I. For initial therapy, all of the following: A. One of the following:

1. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise

in the diagnosis of CLN2 2. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a physician in consultation

with a neurologist with expertise in the diagnosis of CLN2 and

B. Patient is age 3 years or older; and C. All of the following scores on the Clinical Scoring System for LINCL:

1. Combined score of 3 to 6 in the motor and language domains 2. Score of at least 1 in the motor domain 3. Score of at least 1 in the language domain and

D. One of the following: 1. Brineura is prescribed by a neurologist with expertise in the treatment of CLN2

2. Brineura is prescribed by a physician in consultation with a neurologist with expertise in the treatment of CLN2

and E. Brineura is to be administered intraventricularly by, or under the direction of, healthcare professionals

experienced in performing intraventricular infusions via an intracerebroventricular catheter; and

F. Dosing is in accordance with the United States Food and Drug Administration approved labeling: 300 mg administered once every other week as an intraventricular infusion; and

G. Initial authorization will be for no more than 6 months. II. For continuation therapy, all of the following:

A. One of the following: 1. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise

in the diagnosis of CLN2 2. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a physician in consultation

with a neurologist with expertise in the diagnosis of CLN2 and

B. Patient is age 3 years or older; and C. Patient has a score of 1 or higher in the motor domain of the Clinical Scoring System for LINCL; and

D. One of the following: 1. Brineura is prescribed by a neurologist with expertise in the treatment of CLN2 2. Brineura is prescribed by a physician in consultation with a neurologist with expertise in the treatment of




NEW

Brineura™ (Cerliponase Alfa) (continued)

Sep. 1, 2017 CLN2 and

E. Brineura is to be administered intraventricularly by, or under the direction of, healthcare professionals

experienced in performing intraventricular infusions via an intracerebroventricular catheter; and F. Dosing is in accordance with the United States Food and Drug Administration approved labeling: 300 mg

administered once every other week as an intraventricular infusion; and

G. Reauthorization will be for no more than 6 months. Brineura (cerliponase alfa) is unproven and not medically necessary for other forms of Neuronal Ceroid Lipofuscinosis.

Radicava™ (Edaravone)

Sep. 1, 2017

Radicava (edaravone) is proven and medically necessary for the treatment of amyotrophic lateral sclerosis (ALS) in patients who meet all of the following criteria: I. For initial therapy, all of the following:

A. Submission of medical records (e.g., chart notes, previous medical history, diagnostic testing including:

imaging, nerve conduction studies, laboratory values) to support one of the following:

1. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria, and prescribed by a neurologist with expertise in the diagnosis of ALS; or

2. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria, and prescribed by a physician in consultation with a neurologist with expertise in the diagnosis of ALS;

and B. Submission of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score confirming that the

patient has scores ≥ 2 in all items of the ALSFRS-R criteria at the start of treatment; and

C. Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a % forced vital capacity (%FVC) ≥ 80% at the start of treatment; and

D. Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling; and

E. Initial authorization will be for no more than 6 cycles (64 doses over 168 days).

II. For continuation therapy, all of the following:

A. One of the following: 1. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria,

and prescribed by a neurologist with expertise in the diagnosis of ALS; or 2. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria,

and prescribed by a physician in consultation with a neurologist with expertise in the diagnosis of ALS;

and B. Patient is currently receiving Radicava therapy; and C. Patient is not dependent on invasive ventilation or tracheostomy; and D. Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved

http://www.outcomes-umassmed.org/als/alsscale.aspx




NEW

Radicava™ (Edaravone) (continued)

Sep. 1, 2017 labeling; and E. Authorization will be for no more than 6 cycles (60 doses over 168 days).

White Blood Cell Colony Stimulating

Factors

Sep. 1, 2017

The policy refers to the following drug products: White Blood Cell Colony Stimulating Factors (CSFs): Granix

Leukine Neulasta Neupogen

Zarxio For the coverage criteria below, in absence of specified drug products, the term “colony stimulating factors” or “CSFs” will be used in this policy where the coverage criteria apply to all products listed above. I. Bone marrow/stem cell transplant (Leukine, Neupogen, Zarxio)

Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. One of the following:

1. Patient has non-myeloid malignancies and is undergoing myeloablative chemotherapy followed by autologous or allogeneic bone marrow transplant (BMT); or

2. Used for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; or

3. Patient has had a peripheral stem cell transplant (PSCT) and have received myeloablative chemotherapy;

and B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and C. Prescribed by or in consultation with a hematologist or oncologist.

II. Acute myeloid leukemia (AML) induction or consolidation therapy (Leukine, Neupogen, Zarxio)


A. Diagnosis of AML; and B. Patient has completed either induction or consolidation chemotherapy; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and D. Prescribed by or in consultation with a hematologist or oncologist.

III. Neutropenia associated with cancer chemotherapy – dose dense chemotherapy (Leukine, Neulasta,




NEW

White Blood Cell Colony Stimulating Factors

(continued)

Sep. 1, 2017

Neupogen, Zarxio) Leukine, Neulasta, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. One of the following: 1. Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy

protocol for primary breast cancer; or

2. Patient is receiving a dose-dense chemotherapy regimen for which the incidence of febrile neutropenia (FN) is unknown;



IV. Primary prophylaxis of chemotherapy-induced febrile neutropenia (FN) (Granix, Leukine, Neulasta,

Neupogen, Zarxio) White blood cell colony stimulating factors are proven and medically necessary when all of the following

criteria are met:

A. One of the following:

1. Patient is receiving chemotherapy regimen(s) associated with > 20% incidence of FN; or 2. Both of the following:

a. Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN; and b. Patient has one or more risk factors associated with chemotherapy-induced infection, FN, or

neutropenia (see the list of risk factors in the Clinical Evidence section of the policy);



V. Secondary prophylaxis of febrile neutropenia (FN) (Granix, Leukine, Neulasta, Neupogen, Zarxio)

White blood cell colony stimulating factors are proven and medically necessary when all of the following

criteria are met:

A. Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (ANC ≤ 500 cells/mm3); and

B. Patient has a history of FN during a previous course of chemotherapy; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and

D. Prescribed by or in consultation with a hematologist or oncologist. VI. Treatment of Febrile Neutropenia (Leukine, Neulasta, Neupogen, Zarxio) [off-label]




NEW


(continued)

Sep. 1, 2017

Leukine, Neulasta, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (ANC ≤ 500 cells/mm3);

and B. Diagnosis of FN and patient is considered high risk for infection-associated complications; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and

D. Prescribed by or in consultation with a hematologist or oncologist. VII. Severe Chronic Neutropenia (SCN) (Neupogen, Zarxio)

Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. Diagnosis of SCN (i.e., congenital, cyclic, and idiopathic neutropenias with chronic ANC ≤ 500 cells/mm3) B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling C. Prescribed by or in consultation with a hematologist or oncologist

VIII. HIV-related neutropenia (Leukine, Neupogen, Zarxio) [off-label]


A. Diagnosis of HIV infection; and B. Patient has an ANC ≤ 1,000 (cells/mm3) ; and

C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and

D. Prescribed by or in consultation with a hematologist, oncologist or infectious disease specialist.

IX. Hepatitis-C treatment related neutropenia (Neupogen) [off-label] Neupogen is proven and medically necessary when all of the following criteria are met:

A. One of the following: 1. All of the following:

a. Diagnosis of Hepatitis C virus; and b. Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon

alfa-2a); and c. Documentation of neutropenia (ANC ≤ 500 cells/mm3) after dose reduction of Peg-Intron or Pegasys;

or 2. Both of the following:

a. Documentation of interferon-induced neutropenia (ANC ≤ 500 cells/mm3) due to treatment with Peg-

Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a); and b. One of the following:

i. Diagnosis of HIV co-infection; or ii. Status post liver transplant; or




NEW


(continued)

Sep. 1, 2017 iii. Diagnosis of established cirrhosis and

B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;



UPDATED

17-Alpha-

Hydroxyproge-sterone Caproate (Makena™ and 17P)

Jul. 1, 2017

Reformatted and reorganized

policy; transferred content to new template o Changed policy type

classification from “Drug Policy” to “Medical Benefit Drug Policy” to clarify policy

guidelines apply to drug coverage provided under the

medical benefit Removed list of applicable ICD-9

codes (discontinued Oct. 1, 2015)

Updated list of applicable HCPCS

codes to reflect quarterly code edits; added Q9985 and Q9986

Updated supporting information to reflect the most current clinical evidence, CMS information, and references

17-alpha-hydroxyprogesterone caproate, commonly called 17P, may also be

referred to as 17-OHP, 17-OHPC, 17Pc, Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. Hereafter, it will be referred to as 17P. Note: Oral and intravaginal formulations of progesterone are not addressed in this policy.

Intramuscular injection of 17P is proven and medically necessary for

prevention of spontaneous preterm birth when all of the following criteria are met: I. Current singleton pregnancy; and II. History of a prior spontaneous preterm birth of a singleton pregnancy;

and

III. Treatment is initiated between 16 weeks, 0 days of gestation and 26 weeks, 6 days of gestation; and

IV. Administration is to continue weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Intramuscular injection of 17P is unproven and not medically necessary for:

I. Prevention of spontaneous preterm birth with any of the following: A. Short cervix with or without cerclage and no prior preterm birth. B. Current mutli-fetal pregnancy (twins or greater). C. Previous medically indicated preterm birth.

II. Initiation of 17P after 26 weeks, 6 days of gestation.

Although there are ongoing clinical trials to broaden the indications for the use of 17P, at this time uses as indicated above are considered unproven.




UPDATED

17-Alpha-Hydroxyproge-sterone Caproate

(Makena™ and 17P) (continued)

Jul. 1, 2017 *Additional Information regarding compounded 17P: The active ingredient in the compounded 17P and Makena is hydroxyprogesterone caproate. Both have castor oil as an inactive

ingredient. The compounded version can be made with an alternate oil base in the event of patient hypersensitivity to castor oil. Makena has the additional inactive ingredients of benzyl benzoate and benzyl alcohol (a

preservative). Based on the active ingredient, compounded preservative-free 17P is considered clinically interchangeable with Makena. Compounding pharmacies must comply with United States Pharmacopeia

(USP) Chapter 797, which sets standards for the compounding, transportation, and storage of compounded sterile products (CSP).1 The Pharmacy Compounding Accreditation Board will verify that the pharmacy is adhering to these standards.2 *Note: The FDA has stated that approved drug products provide a greater

assurance of safety and effectiveness than do compounded products. Please refer to the U.S. Food and Drug Administration (FDA) section of this policy

for additional information.

Stelara® (Ustekinumab)

Jul. 1, 2017

Updated list of applicable HCPCS codes to reflect quarterly code

edits: o Added Q9989 o Removed J3590

This policy refers to Stelara (ustekinumab) injection.

Stelara is proven and medically necessary for the treatment of: I. Crohn’s disease when all of the following criteria are met:

A. Diagnosis of moderately to severely active Crohn’s disease; and B. One of the following:

1. History of failure, contraindication, or intolerance to at least one tumor necrosis factor (TNF) blocker [e.g., Remicade/Inflectra (infliximab), Humira (adalimumab), Cimzia (certolizumab)]; or

2. Both of the following:

a. History of failure, contraindication, or intolerance to at least one immunomodulator or corticosteroid (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.)

b. Patient has never failed a TNF blocker [e.g.,

Remicade/Inflectra (infliximab), Humira (adalimumab), Cimzia (certolizumab)]

and C. One of the following:




UPDATED

Stelara® (Ustekinumab) (continued)

Jul. 1, 2017

1. Initial Therapy a. Stelara is to be administered as an intravenous induction

dose; and

b. Stelara induction dosing is accordance with the United States Food and Drug Administration approved labeled dosing for Crohn’s disease:

i. 260mg for patients weighing ≤55kg ii. 390mg for patients weighing >55kg to ≤85kg iii. 520mg for patients weighing >85kg and

c. Patient is not receiving Stelara in combination with any of the following: i. Biologic DMARD [e.g., Remicade/Inflectra (infliximab),

Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

ii. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

iii. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

and d. Authorization will be for one induction dose. or

2. Continuation Therapy a. Patient is unable to self-administer subcutaneous doses; and

b. Stelara is to be subcutaneously administered 8 weeks after the initial intravenous dose; and

c. Stelara continuation dosing is in accordance with the United States Food and Drug Administration approved labeled dosing for Crohn’s disease: i. 90mg every 8 weeks subcutaneously and

d. Patient is not receiving Stelara in combination with any of the following: i. Biologic DMARD [e.g., Remicade/Inflectra (infliximab),

Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

ii. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

iii. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]




UPDATED


Jul. 1, 2017

II. Plaque psoriasis when all of the following criteria are met:

A. Diagnosis of moderate to severe plaque psoriasis; and B. One of the following:

1. Patient is a candidate for phototherapy; or 2. Patient is a candidate for systemic therapy; and

C. Patient is unable to self-administer subcutaneous doses; and D. Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for plaque psoriasis up to a maximum of (or equivalent dose and interval schedule):

1. 45mg every 12 weeks for patients weighing ≤100kg subcutaneously;

2. 90mg every 12 weeks for patients weighing >100kg subcutaneously;

and E. Patient is not receiving Stelara in combination with any of the

following: 1. Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]. 2. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)].

3. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)].

III. Psoriatic arthritis when all of the following criteria are met:

A. Diagnosis of psoriatic arthritis; and B. Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and

C. Patient is unable to self-administer subcutaneous doses; and D. Patient is not receiving Stelara in combination with any of the

following: 1. Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]. 2. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)].

3. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)].

Stelara is unproven and not medically necessary for the treatment of: I. Multiple sclerosis




UPDATED


Jul. 1, 2017 In available studies, Stelara does not demonstrate efficacy in the treatment of multiple sclerosis.


REVISED

Off-Label/Unproven Specialty Drug Treatment

Aug. 1, 2017

Changed policy type classification from “Drug Policy” to “Medical Benefit Drug Policy”

to clarify policy guidelines apply to drug coverage provided under the medical benefit

Revised coverage rationale/criteria for a specialty drug to be considered medically

necessary for an off-label or unproven indication:

o Added criterion requiring “the requested drug has not been excluded from coverage by UnitedHealthcare due to lack

of efficacy, clinical benefit, or administrative program (e.g., exclusion at launch, plan document)”

o Replaced reference to “MCG™ Ambulatory Care Guideline” with “MCG™ Care

Guidelines, Ambulatory Care”

Updated supporting information to reflect the most current references o Replaced reference to

“MCG™ Ambulatory Care 19th edition” with “MCG™ Care Guidelines, Ambulatory

Description

This policy provides parameters for coverage of off-label and unproven indications of FDA-approved medications covered under the medical benefit for one of the following:* Injectable specialty drug with a corresponding UnitedHealthcare policy

that does not address the requested indication. Injectable specialty drug with a corresponding UnitedHealthcare policy

that lists the drug as unproven for the requested indication. Injectable specialty drug without a UnitedHealthcare drug policy.

* http://www.uhcspecialtyrx.com/

This policy does not address coverage for medications covered under the pharmacy benefit. Please refer to pharmacy benefit coverage.

This policy does not address coverage of injectable oncology medications (J9000 - J9999) and select other medications used for oncology conditions [including, but not limited to octreotide acetate (J2353 and J2354) and leuprolide acetate (J1950)] covered under the medical benefit based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™. Please refer to the Medical Benefit Drug Policy titled Oncology Medication Clinical Coverage Policy for more information.

This policy does not address coverage of vaccines. Please refer to the

Medical Benefit Drug Policy titled Vaccines and the Coverage Determination Guideline titled Preventative Care Services for additional information on vaccines covered as preventive services. Indications of Coverage

A specialty drug may be determined medically necessary for the requested

off-label or unproven indication when all of the criteria are met: I. The drug is approved by the U.S. Food and Drug Administration; and II. The requested drug has NOT been excluded from coverage by

http://www.uhcspecialtyrx.com/




REVISED

Off-Label/Unproven Specialty Drug Treatment

(continued)

Aug. 1, 2017 Care, 21st edition”

UnitedHealthcare due to lack of efficacy, clinical benefit, or administrative program (e.g., exclusion at launch, plan document); and

III. One of the following:

A. The requested drug is considered ‘unproven’ per UnitedHealthcare drug policy, where applicable

B. The indication for the requested drug is not addressed by a

UnitedHealthcare drug policy, where applicable C. A UnitedHealthcare drug policy does not exist for the requested drug. and

IV. The drug is prescribed by a licensed health care professional; and

V. The requested drug is intended to treat a chronic and seriously debilitating condition; and

VI. Documented history of failure, contraindication, or intolerance to standard, conventional therapies to treat or manage the disease or condition, where available; and

VII. Diagnosis is clinically supported as a use by at least One of the

following: A. One of the following compendia:

1. The American Hospital Formulary Service Drug Information (AHFS-DI) under the Therapeutic Uses section; or

2. The Elsevier Gold Standard’s Clinical Pharmacology under the Indications section; or

3. (3) DRUGDEX System by Micromedex® has a Strength of

Recommendation rating of Class I, Class IIa, or Class IIb under the Therapeutic Uses section3;

or B. MCG™ Care Guidelines, Ambulatory Care; or C. Two (2) articles from major peer reviewed medical journals that

present data supporting the proposed off-label use or uses as generally safe and effective unless there is validated and uncontested

contradictory evidence presented in a major peer-reviewed medical journal. [Examples of accepted journals include, but are not limited to, Journal of American Medical Association, New England Journal of Medicine, and Lancet. Accepted study designs may include, but are not limited to, randomized, double blind, placebo controlled clinical

trials.]




UPDATED

Cosmetic and Reconstructive Procedures

Jul. 1, 2017

Updated list of applicable CPT codes: o Revised description for

19324 o Updated coding clarification

language for flaps (skin

and/or deep tissue) procedures (CPT codes 15570-15738); removed language indicating the

regions listed refer to a donor site when a tube is formed for later transfer or when a "delay" of flap occurs prior to the transfer

Updated definitions; revised

definition of “cosmetic procedures” and “sickness

Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the

member specific benefit plan document. Indications for Coverage

Criteria for a Procedure to be Considered Reconstructive and Medically Necessary

There is documentation that the physical abnormality and/or physiological abnormality is causing a functional impairment (as defined in the Definitions section of the policy) that requires correction.

The proposed treatment is of proven efficacy and is deemed likely to significantly improve or restore the patient’s physiological function.

Microtia repair (as defined in the Definitions section of the policy) is

reconstructive; although no functional impairment may be documented for Microtia, this has been deemed reconstructive surgery.

Coverage Limitations and Exclusions

Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the member specific benefit plan document. Cosmetic Procedures are excluded from coverage. Procedures that

correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in

the Indications for Coverage section is excluded from coverage.

Pectus Deformity Repair

Jul. 1, 2017

Updated definition of “sickness” (no change to coverage rationale or lists of applicable codes)

Indications for Coverage

Surgical repair of pectus excavatum is considered reconstructive and medically necessary when the following criteria has been met: Pectus Excavatum

Imaging studies confirm Haller index greater than 3.25; and




UPDATED

Pectus Deformity Repair (continued)

Jul. 1, 2017 A functional impairment defined in physician current office notes; and o For restrictive lung capacity the total lung capacity is documented in

the physician current office notes as <80% of the predicted value; or

o There is cardiac compromise as demonstrated by decreased cardiac output on the echocardiogram; or

o There is objective evidence of exercise intolerance as documented by

cardiopulmonary exercise testing that is below the predicted values. Pectus Carinatum

It is extremely uncommon that pectus carinatum will cause a functional/physiological deficit. Pectus carinatum is not a congenital anomaly; it is a developmental condition of the cartilage that generally

occurs during an adolescents growth spurt. (Goretsky, 2004) Requests for coverage of repair of pectus carinatum will be reviewed by a UnitedHealthcare Medical Director on a case-by-case basis. Coverage Limitations and Exclusions

Some states require benefit coverage for services that UnitedHealthcare

considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional/ physical impairment. Please refer to the member specific benefit plan document.

Cosmetic Procedures are excluded from coverage. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer functional/psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve

such consequences or behavior) as a reconstructive procedure. Any procedure that does not meet the reconstructive criteria above in

the Indications for Coverage section.

Rhinoplasty and Other Nasal

Surgeries

Jul. 1, 2017

Updated list of applicable codes; added notation to clarify all nasal

surgical claims may be subject to coding review

Updated supporting information to reflect the most current references


Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the

member specific benefit plan document.

Rhinoplasty-Primary (CPT Codes 30410, 30420)

Rhinoplasty-primary is considered reconstructive and medically




UPDATED

Rhinoplasty and Other Nasal Surgeries

(continued)

Jul. 1, 2017

necessary when all of the following criteria are present: Prolonged, persistent obstructed nasal breathing due to nasal bone and

septal deviation that are the primary causes of an anatomic mechanical

nasal airway obstruction, and The nasal airway obstruction cannot be corrected by septoplasty alone as

documented in the medical record, and

Photos clearly document the nasal bone/septal deviation as the primary cause of an anatomic mechanical nasal airway obstruction and are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic mechanical

nasal airway obstruction and relieve the nasal airway obstruction by centralizing the nasal bony pyramid (30410) and also straightening the septum (30420), and

One of the following is present: o Nasal fracture with nasal bone displacement severe enough to cause

nasal airway obstruction, or

o Residual large cutaneous defect following resection of a malignancy or nasal trauma, and

Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing), and

Obstructive symptoms persist despite conservative management for 4 weeks or greater, which includes, where appropriate, nasal steroids or immunotherapy.

Rhinoplasty-Tip (CPT Code 30400)

Rhinoplasty-tip is primarily cosmetic. However, it is considered reconstructive and medically necessary when all of the following criteria are present:

Prolonged, persistent obstructed nasal breathing due to tip drop that is the primary cause of an anatomic mechanical nasal airway obstruction

(this code is usually cosmetic), and Photos clearly document tip drop as the primary cause of an anatomic

mechanical nasal airway obstruction and are consistent with the clinical exam (acute columellar-labial angle), and

The proposed procedure is designed to correct the anatomic mechanical nasal airway obstruction and relieve the nasal airway obstruction by lifting the nasal tip, and

Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing), and




UPDATED


(continued)

Jul. 1, 2017


Rhinoplasty-Secondary (CPT Codes 30430, 30435, 30450)

Rhinoplasty-secondary is primarily cosmetic. However, it is

considered reconstructive and medically necessary when all of the following criteria are present:

Required as treatment of a complication/residual deformity from primary surgery performed to address a functional impairment when a documented functional impairment persists due to the complication/deformity (these codes are usually cosmetic), and

Photos clearly document the secondary deformity/complication as the primary cause of an anatomic mechanical nasal airway obstruction and

are consistent with the clinical exam, and The proposed procedure is designed to correct the anatomic mechanical

nasal airway obstruction and relieve the nasal airway obstruction by correcting the deformity or treating the complication (these codes are

usually cosmetic), and Nasal airway obstruction is causing significant symptoms (e.g., chronic

rhinosinusitis, difficulty breathing), and


Rhinoplasty for Congenital Anomalies (CPT Codes 30460, 30462)

The following are considered reconstructive and medically necessary when the following are present: Rhinoplasty is considered reconstructive when performed for a nasal

deformity associated with congenital craniofacial anomalies including, but not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder

Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft (most commonly #1) or associated with a cleft lip or cleft palate.

Repair of Nasal Vestibular Stenosis or Alar Collapse (CPT Code 30465)

Repair of nasal vestibular stenosis or alar collapse is considered

reconstructive and medically necessary when all of the following criteria are present: Prolonged, persistent obstructed nasal breathing due to internal and/or




UPDATED


(continued)

Jul. 1, 2017

external nasal valve compromise (see Definitions section of the policy), and

Internal valve compromise due to collapse of the upper lateral cartilage

and/or external nasal valve compromise due to collapse of the alar (lower lateral) cartilage resulting in an anatomic mechanical nasal airway obstruction that is a primary contributing factor for obstructed nasal

breathing, and Photos clearly document internal and/or external valve collapse as the

primary cause of an anatomic mechanical nasal airway obstruction and are consistent with the clinical exam, and

Other causes have been eliminated as the primary cause of nasal obstruction (e.g., sinusitis, allergic rhinitis, vasomotor rhinitis, nasal polyposis, adenoid hypertrophy, nasopharyngeal masses, nasal septal deviation, turbinate hypertrophy and choanal atresia).

Septal Dermatoplasty (CPT Code 30620)

Septal dermatoplasty is considered reconstructive when: There is a documented functional impairment (e.g., obstruction, pain or

bleeding) due to diseased nasal mucosa, and The functional impairment will be eliminated by a skin graft.

Lysis Intranasal Synechia (CPT Code 30560)

Lysis intranasal synechia is considered reconstructive when: There is a documented functional impairment (e.g., obstruction, pain or

bleeding) due to intranasal synechia (adhesions/scar bands), and The functional impairment will be eliminated by lysis of the synechia.

Rhinophyma (CPT Code 30120)

Rhinophyma is considered reconstructive and medically necessary when all of the following criteria are present: One of the following:

o Prolonged, persistent obstructed nasal breathing due to rhinophyma, or

o Chronic infection or bleeding unresponsive to medical management due to rhinophyma, and

Photos clearly document rhinophyma as the primary cause of an anatomic mechanical nasal airway obstruction or chronic infection and

are consistent with the clinical exam, and The proposed procedure is designed to correct the anatomic mechanical

nasal airway obstruction and relieve the nasal airway obstruction by




UPDATED


(continued)

Jul. 1, 2017

correcting the deformity or the proposed procedure is designed to address the chronic infection.

California Only

This is the mandated language for Reconstructive Procedures: Reconstructive procedures to correct or repair abnormal structures of the

body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease. Reconstructive procedures include

surgery or other procedures which are associated with an Injury, Sickness or Congenital Anomaly. The primary result of the procedure is not a changed or improved physical appearance for cosmetic purposes only, but rather to improve function and/or create a normal appearance, to the extent possible.

Documentation Requirements

Rhinoplasty or other nasal surgery documentation should include the evaluation and management note for the date of service and the note for the day the decision to perform surgery was made. The member’s medical record

must contain, and be available for review on request, the following

information: Physician office notes Radiologic imaging if done Photographs that document the nasal deformity. Coverage Limitations and Exclusions

Cosmetic Procedures are excluded from coverage, including but not limited to: Procedures that correct an anatomical Congenital Anomaly without

improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological

consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure

Rhinoplasty, unless rhinoplasty criteria above are met

Any procedure that does not meet the reconstructive criteria Rhinoplasty procedures performed to improve appearance (check the

member specific benefit plan document)




REVISED

Preventive Care Services

Oct. 1, 2017

Updated coverage rationale/indications for coverage:

Pediatrics o Clarified list of services

covered under the

preventive care benefit for children (of the appropriate age); replaced “counseling for fluoride for prevention of dental cavities” with “application of fluoride by a

primary care provider for prevention of dental cavities”

Revised list of applicable procedure and diagnosis codes for:

Preventive Care Services

Colorectal Cancer Screening

o Updated list of applicable procedure codes for fecal occult blood testing (FOBT), fecal immunochemical test (FIT), fecal DNA, sigmoidoscopy, or

colonoscopy: Modified Code Group 5

for pre-op/consultation; removed CPT codes 99241, 99242, 99243,

99244, and 99245

Preeclampsia Screening (new to

policy) o Added language to indicate:

The USPSTF recommends screening

for preeclampsia in pregnant women with blood pressure

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.




REVISED

Preventive Care Services (continued)

Oct. 1, 2017 measurements throughout pregnancy (USPSTF Rating: B)

Preeclampsia screening by blood pressure measurement is included

in the code for a wellness examination visit; see section titled Wellness Examinations

for applicable procedure codes

See section titled Wellness Examinations for applicable preventive benefit instructions

Expanded Women’s Preventive Health

Breastfeeding Support, Supplies,

and Counseling o Updated list of applicable

procedure codes for support and counseling; removed

CPT codes 99241, 99242, 99243, 99244, and 99245

Private Duty Nursing Services (PDN)

Aug. 1, 2017

Updated coverage rationale/requirements for coverage; added instruction to

refer to the Definitions section of

the policy for applicable service descriptions

Revised definition of: o Custodial care o Intermittent care

o Private duty nursing o Skilled care

Updated supporting information to reflect the most current


Before using this guideline, refer to the member specific benefit plan document and any federal or state mandates to determine if the plan has an exclusion for Private Duty Nursing. If the plan has the exclusion for Private

Duty Nursing, then the services are not eligible for coverage. When Private

Duty Nursing is a covered benefit, please refer to the member specific benefit plan document for additional information regarding benefit coverage. Requirements for Coverage

The services requested must meet all of the following: Be ordered and directed by the treating practitioner or specialist (M.D.,

D.O., P.A. or N.P) after a face-to-face evaluation by the physician, licensed or certified physician assistant or nurse practitioner, and




REVISED


(continued)

Aug. 1, 2017

references

services are: o Skilled Care services (please see Coverage Determination Guideline

titled Skilled Care and Custodial Care Services)

o Required on a continuous basis rather than short term intermittent care

o Subject to frequent reassessments and changes in treatment

o Private Duty Nursing services provided in the home o Not Custodial Care

A written treatment plan and a letter of medical necessity must be submitted by the treating practitioner or specialist (M.D., D.O., P.A. or

N.P) with the request for specific services and equipment; and Continuation of services requires documentation to support the need for

ongoing treatment; and Private Duty Nursing Care services must be clinically appropriate and not

more costly than alternative health services.

Please refer to the Definitions section of the policy.

Note: The absence of an available caregiver does not make the requested services Skilled Care. Plans may require the caregiver to provide a certain number of hours of care for the patient. Check the member specific benefit plan document or the

federal or state mandate requirements for the maximum number of Private Duty Nursing hours. Coverage Limitations and Exclusions

Services beyond the plan benefits (hours or days) Requested services are excluded in the benefit documents or state

specific contracts

Requested services are defined as non-skilled or Custodial Care in the member specific benefit plan document (refer to the Coverage

Determination Guideline titled Skilled Care and Custodial Care Services, the member specific benefit plan document, or any federal or state mandate requirements)

Respite care and convenience care unless mandated (respite care relieves the caregiver of the need to provide services to the patient)

Services that can be provided safely and effectively by a non-clinically trained person are not skilled when a non-skilled caregiver is not




REVISED


(continued)

Aug. 1, 2017

available Services that involve payment of family members or nonprofessional

caregivers for services performed for the member unless required by

state contract Services when the member does not meet criteria for Skilled Care

services

Member is no longer eligible for benefits under the plan or any federal or state mandate requirements



Policy Title Effective Date Summary of Changes Utilization Management Guiding Principles

REVISED

Office Based Program

Oct. 1, 2017

Updated list of related policies; added reference link to Medical Policy titled Surgical and Ablative

Procedures for Venous Insufficiency and Varicose Veins

Revised list of applicable CPT

codes for elective procedures requiring prior authorization if not performed in the office setting; added:

Dermatology o 10120, 10140, 11400,

11401, 11404, 11420, 11421, 11423, 11424, 11426, 11442, and 11606

Gastroenterology

o 45300, 45330, and 46922 General Surgery

o 19000 Muscular/Skeletal o 64520 Obstetrics & Gynecology o 57460

Urology o 55250 Vascular o 36473, 36475, and 36478

Introduction

In an effort to minimize out-of-pocket costs for UnitedHealthCare members and to improve cost efficiencies for the overall health care system, we are implementing prior authorization guidelines that aim to encourage more cost-effective sites of service for certain outpatient surgical procedures, when

medically appropriate.

These prior authorization requirements apply to UnitedHealthcare commercial plans that require services to be medically necessary, including being cost-effective. Refer to the member specific benefit plan document to determine if medical necessity applies.

Specific procedure codes for services can be found on the Prior Authorization List (refer to the References section of the policy). Coverage Rationale

With the exception of the qualifying conditions below, certain elective procedures should be performed in an office setting.

The following will be taken into account to determine whether the elective procedure is being performed in a cost-effective setting:

Members benefit plan Geographic availability of an in-network provider Office capability (i.e., appropriate equipment) Significant member comorbidities (see list of examples of Qualifying

Conditions below) Certain Qualifying Conditions

Some patients may require more complex care due to certain medical factors or functional limitations and it may be appropriate to have the procedure in

an outpatient hospital setting or ambulatory surgery center (not an all-inclusive list): Patient unable to cooperate with procedure due to mental status, severe

anxiety, or extreme pain sensitivity Failed office based procedure attempt due to body habitus, abnormal

anatomy, or technical difficulties

Bleeding disorder that would cause a significant risk of morbidity Allergy to local anesthetic



Policy Title Effective Date Summary of Changes Utilization Management Guiding Principles

REVISED

Office Based Program (continued)

Oct. 1, 2017 Potential Documentation Requirements

Physician office notes Elective Procedures List

Prior authorization is required for the following procedures if not performed in an office setting (see Applicable Codes table).

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